Status:
COMPLETED
Prevention of Necrotizing Enterocolitis of Premature Newborns Under Less Than 1500 g Using Probiotics
Lead Sponsor:
Coordinación de Investigación en Salud, Mexico
Conditions:
Infectious Diseases
Eligibility:
All Genders
27-34 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the incidence of necrotizing enterocolitis and its effect over the secreting immunoglobulin A in the feces with the use of probiotics of the strain Lactobacill...
Detailed Description
Randomized controlled trial, in the Neonatal department of Highly Specialized Medical Unit (UMAE) of Hospital Pediatric - Gynecology No. 48 of Mexican Institute of Social Security (IMSS ) on Leon, Mex...
Eligibility Criteria
Inclusion
- All of the premature newborns of 34 weeks of gestational age, and with a weight between 700 to 1500 g. that are admitted in the Neonatal Intensive Care Unit or the Neonatology Department that have no contraindication for oral intake in the first 7 days of life. Must not have been diagnosed of sepsis of early onset, prenatal asphyxia, patent ductus arterious with hemodynamic repercussion, major congenital malformations. In all cases the parents or legal guardian must sign the informed consent.
Exclusion
- All preterm newborns younger than 34 weeks of gestational age that develop any disease different of (NEC) that require to stop the enteral feeding for more than seven days or whose parents or legal guardians revoke the informed consent form.
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT02245815
Start Date
December 1 2013
End Date
July 1 2015
Last Update
January 28 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Guanajuato School of Medicine
León, Guanajuato, Mexico, 37000